FDA Product Code LDF: Electrode, Pacemaker, Temporary
Temporary pacemakers provide immediate cardiac pacing during hemodynamic emergencies. FDA product code LDF covers temporary pacemaker electrodes used for short-term cardiac stimulation.
These catheters are placed transvenously or epicardially to deliver electrical impulses to the myocardium for temporary rate support during symptomatic bradycardia, post-cardiac surgery, and as a bridge to permanent pacemaker implantation.
LDF devices are Class II medical devices, regulated under 21 CFR 870.3680 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Medtronic Vascular, C.R. Bard, Inc. and Electro-Catheter Corp..
129
Total
129
Cleared
134d
Avg days
1978
Since
129 devices
Cleared
Jan 16, 1981
SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.
American Edwards Laboratories
Cardiovascular
45d
Cleared
Apr 16, 1980
USCI BIPOLAR BALLON PACING ELECTRODE
C.R. Bard, Inc.
Cardiovascular
65d
Cleared
Jul 12, 1979
SWAN-GANZ FLOW-DIRECTED CATHETER
Edwards Lifesciences, LLC
Cardiovascular
17d
Cleared
Dec 04, 1978
TEMPORARY CARDIAC PACING WIRE
Ethicon, Inc.
Cardiovascular
172d